COMMAND Brain-Computer Interface for Paralysis

• Sponsor: Synchron Medical, Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05035823
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.

The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

Condition or Disease	Intervention/Treatment	Phase
Neurologic Disorder; Paralysis; Paralysis; Stroke; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Spinal Cord Injuries; Stroke, Lacunar; Stroke Brainstem; Cervical Spinal Cord Injury; Spinal Muscular Atrophy; Tetraplegic; Paralysis; Quadriplegia/Tetraplegia	Device: Motor Neuroprosthesis (MNP)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Motor NeuroProsthesis to Restore Motor Control for the COMMAND of Digital Devices: An Early Feasibility Study (EFS) of Safety in Subjects With Severe Quadriparesis
• Actual Study Start Date: Apr 27, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Implantation of the motor neuroprosthesis medical device.	Device: Motor Neuroprosthesis (MNP); Type of implantable brain computer interface

Outcome Measures

Primary Outcome Measures

1. Treatment-Related Serious Adverse Events [12 months post implant]

   Number of subjects with treatment-related adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Severe quadriparesis

2. Able to give consent

3. Appropriate candidate for neurointerventional procedure

4. Able and willing to access all clinical testing and not impeded by geographical location

5. Proficient in English

6. Have a study partner

Exclusion Criteria:

1. Active condition resulting in immunosuppression

2. Unsuitable for general anesthesia

3. Anaphylactic allergy to contrast media

4. Allergy to nickel

5. History of pulmonary embolism

6. History of recent deep vein thrombosis

7. Psychiatric or psychological disorder

8. No study partner or caregiver

9. Unable to provide evidence of COVID vaccination

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Health System	New York	New York	United States	10029

Sponsors and Collaborators

• Synchron Medical, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Synchron Medical, Inc
• ClinicalTrials.gov Identifier: NCT05035823
• Other Study ID Numbers: COMMAND
• First Posted: Sep 5, 2021
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Muscular Dystrophies; Stroke; Spinal Cord Injuries; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Muscular Atrophy; Paralysis; Muscular Atrophy, Spinal; Quadriplegia; Nervous System Diseases; Stroke, Lacunar; Wounds and Injuries

Study Results

No Results Posted as of Aug 3, 2022